Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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TempTraq Patient iOS App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006371 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006364 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician Web App
Not in Commercial Distribution

  • 00851203006173 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Clinician iOS App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician iOS App
Not in Commercial Distribution

  • 00851203006142 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Patient iOS App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Patient iOS App
Not in Commercial Distribution

  • 00851203006135 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician Android App
Not in Commercial Distribution

  • 00851203006128 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Patient Android App
Not in Commercial Distribution

  • 00851203006111 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Consumer iOS App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Consumer iOS App
Not in Commercial Distribution

  • 00851203006043 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Consumer Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Consumer Android App
Not in Commercial Distribution

  • 00851203006036 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder
Sirona B iOS App
DATRIX LLC
RX22674
In Commercial Distribution

  • 00851074007132 ()


  • Telemetric electrocardiographic ambulatory recorder
Sirona B PC App
DATRIX LLC
RX22673
In Commercial Distribution

  • 00851074007125 ()


  • Telemetric electrocardiographic ambulatory recorder
Bionic Circle App, Android
Beta Bionics, Inc.
BOM000083
In Commercial Distribution

  • 00850050080176 ()
BB5002

  • Ambulatory insulin infusion pump software, data-display
Bionic Circle App, iOS
Beta Bionics, Inc.
BOM000082
In Commercial Distribution

  • 00850050080169 ()
BB5001

  • Ambulatory insulin infusion pump software, data-display
Beyond App Android 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689112 ()
5 300 0009 001

  • Hearing aid/implant system remote control
Beyond App iOS 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689105 ()
5 300 0008 001

  • Hearing aid/implant system remote control
Widex ToneLink App Android
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702965 ()
5 300 0017 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Widex ToneLink App iOS
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702958 ()
5 300 0016 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Widex MOMENT App Android
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930320 ()
5 300 0022 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Widex MOMENT App iOS
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930313 ()
5 300 0021 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Vea - Mobile Alignment App
ALPHATEC SPINE, INC.
AIX21000
In Commercial Distribution

  • 00190376470351 ()


  • Orthopaedic/craniofacial implantation planning software
APP replacement pad, deluxe
COMPASS HEALTH BRANDS CORP.
APP-DLXP
In Commercial Distribution

  • 80092237602054 ()
  • 00092237602058 ()


  • Alternating-pressure bed mattress overlay, reusable
APP Replacement pad, basic
COMPASS HEALTH BRANDS CORP.
APP-BPD
In Commercial Distribution

  • 80092237602023 ()
  • 00092237602027 ()


  • Alternating-pressure bed mattress overlay, reusable
Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution

  • 10385083000336 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution

  • 10385083000565 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
CIONIC Android Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000040 ()
62000004

  • Gait-enhancement electrical stimulation system, external
CIONIC iOS Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000030 ()
62000003

  • Gait-enhancement electrical stimulation system, external
DS Replacement APP Pump,
COMPASS HEALTH BRANDS CORP.
DS-NADJP
In Commercial Distribution

  • 30092237617947 ()
  • 00092237617946 ()


  • Alternating-pressure inflator
Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001051 ()


  • Electroencephalograph
An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment to assist process management. It is not intended for control of equipment
NEUROLIEF LTD
RLV-PMI-102
In Commercial Distribution

  • 07290018393147 ()


  • Configurable electronic form web-based application software
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